Kornimate/medical-research-clean huggingface dataset:
a retrospective data collection of compression anastomosis using the colonring

Conditions: Diverticulum, Colon; Colorectal Neoplasms; Crohn Disease; Colitis, Ulcerative; Colostomy; Ileostomy - Stoma; Rectal Prolapse; Intestinal Polyposis; Lymphoma; Endometriosis; Intestinal Volvulus

Summary: the proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the colonring device in routine clinical practice at 4-6 centers. the data will assist in future evaluating the performance of the colonring device in regards to the creation of a colorectal anastomosis in low anterior resection procedures. hypothesis: the performance of the colonring, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.


Eligibility criteria:
inclusion criteria: 1. patient was \> 18 years old at time of procedure 2. patient underwent a technically successful open or laparoscopic colorectal, low anterior resection procedure with the creation of an anastomosis using the colonring™ 3. patient treated in routine clinical practice 4. patient underwent his/her first follow-up visit within two months post-surgery exclusion criteria: no exclusion criteria have been defined for this data collection.

Keywords: compression anastomosis
screening for islet autoantibodies in the israeli paediatric general population for detection of pre-symptomatic type-1 diabetes mellitus

Conditions: Type1diabetes

Summary: a national screening program for children aged 9 months-5 years that will be tested for the presence of islet autoantibodies.up to 50,000 children will be screened by their primary care physician all over israel. the initial screening will be done at the age of 1 year (in conjunction with the routinely collection of blood for cbc ) and repeated at ages 2-5 years. antibodies will be measured in capillary blood samples using the ultrasensitive antibody detection by agglutination-pcr (adap) technology developed by enable biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods. by using this innovative technology in such a large cohort, the study is anticipated to detect antibodies at an unprecedented earlier age.when positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the adap technology. in addition, multiple antibodies will be also measured using a radio-binding assay (rba) of a venous blood sample for investigational purpose only. children with confirmed multiple antibodies (stage 1 or 2 t1d) will be followed up routinely for the appearance of clinical signs of diabetes (hba1c, repeated ogtt, monitoring of urine and blood glucose where indicated) and will be invited along with their families to attend an educational program. this program will include diabetes education emphasizing on dka prevention as well as stress assessment for the families involved and stress alleviating interventions. the analysis and storage of the samples will be done in a single screening center at schneider children's medical center of israel.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities * children aged 9-months- 5 years at first screening. exclusion criteria: * known diagnosis of diabetes (type 1 or other)

Keywords: autoantibodies screening
outcomes and health care resource utilization in pediatric congenital heart disease patients undergoing non-cardiac procedures

Conditions: Congenital Heart Disease in Children

Summary: the incidence of moderate to severe congenital heart disease (chd) in the united states is estimated to be 6 per 1000 live-born full term infants. recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with chd leading to an increase in prevalence in both children and adults. children with chd significant enough to require cardiac surgery frequently also undergo non-cardiac surgical procedures. analysis of the pediatric health information system database between 2004 and 2012 demonstrated that 41% of children who had undergone surgery to correct chd in the first year of life also underwent at least one non-cardiac surgery by age 5. with this increased demand for non-cardiac procedures, anesthesiologists, pediatricians and other healthcare providers will encounter patients with repaired or unrepaired chd and other cardiac diseases in their practice. however, the information provided by national databases lack granularity and the information from single institutional data is limited. this project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. to conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. the aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts.


Eligibility criteria:
inclusion criteria: 1. males or females ages birth to 21 years. 2. patients diagnosed with congenital heart disease 3. patients undergoing a noncardiac procedure (surgical or nonsurgical) exclusion criteria: 1. patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers. 2. patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study

Keywords: perioperative risk prediction adverse postoperative outcomes
analysis of the persistence, reservoir and hiv latency

Conditions: HIV Infected Individuals; Informed Consent

Summary: the april study aims at analyzing hiv reservoirs, latency and persistence on antiretroviral therapy. it enrolls hiv-infected adults providing blood samples of which peripheral blood mononuclear cells are stored. the frequency, phenotype and inducibility of hiv-infected cells are then analyzed. these parameters may vary across the different clinical and therapeutic settings.


Eligibility criteria:
inclusion criteria: * hiv-infection * adults (\>18 years) * social insurance * informed consent exclusion criteria: * hiv-uninfected * \<18 years * lack of social insurance * lack or withdraw of consent

Keywords: hiv reservoir latency persistence
pattern of acute on chronic liver failure in patient with hcv related chronic liver disease

Conditions: Acute-On-Chronic Liver Failure

Summary: the concept of acute-on-chronic liver failure (aclf) was introduced by jalan and williams in 2002 to describe the acute deterioration in liver function over 2 to 4 weeks in a patient with well-compensated cirrhosis associated with a precipitating event (hepatotoxic: superimposed hepatitis viral infection, drug-induced liver injury, hepatotoxins, or excessive alcohol consumption; extra hepatic: variceal bleeding or sepsis), leading to severe deterioration in clinical status with jaundice and hepatic encephalopathy and/or hrs. following this concept, several proposals for the diagnostic criteria of aclf have been suggested.

there may be regional differences in etiology, pathogenesis, and natural course of aclf, which may in turn influence the overall outcome of this syndrome. so, proper diagnosis of aclf and its precipitating factors in our locality enable us for proper management of these cases and dealing with these precipitating factors to be avoided later on in patients with liver cirrhosis aim of the work: to identify the pattern of acute on chronic liver cell failure (aclf) within 28 days including prevalence, percipitating factors, and outcome. patients and methods type of the study: prospective hospital based study site of the study: tropical medicine and gastroenterology department, al-rajhi university hospital, assiut university hospitals, assiut, egypt. written consent will be obtained from all the participants or their relatives before enrollment.

Eligibility criteria:
inclusion criteria: * adult patients with hcv related cld based on clinical, biochemical and imaging evidence., with or without prior decompensation. * patients diagnosed to have aclif at any grade (1-3) exclusion criteria: * acute liver failure without evidence of chronic liver disease. * other etiology of chronic liver disease * patients diagnosed with no aclif no aclf * this category includes patients who either: * do not have any organ failure * have a single organ failure that does not involve the kidney with a serum creatinine level of \<1.5 mg per dl and no hepatic encephalopathy * have a single brain failure with a serum creatinine level of \<1.5 mg per dl * patients refuse to participate.
development and validation of an online treatment program for adjustment disorders

Conditions: Online Computerized Program Group; Waiting List Control Group

Summary: the purpose of this study is to determine the efficacy and effectiveness of a self-help treatment for adjustment disorders administered through a computerized program applied over the internet. this treatment modality will be compared with a waiting list control group. it is expected that, on the one side, the intervention group will improve significantly compared to the waiting list control group. on the other side, it is expected the self-applied online treatment program to be well accepted and valued by the patient.

adjustment disorder (ad) is a highly prevalent health problem that causes a great suffering and can result in suicidal thinking and/or behavior. however, unlike mood and anxiety disorders, ad has received little attention from scientific community and very few studies have been carried out to develop evidence-based treatments (ebt) for this problem. besides, although a cognitive behavioral therapy (cbt) protocol is currently available for the treatment of ad, many patients with this diagnosis remain untreated. there is therefore an evident need to design strategies that guarantee the patients receive adequate treatment. a feasible solution might be self-administered computerized cbt (ccbt). a growing body of research has found that ccbt is highly effective for anxiety and depressive disorders, achieving clinical improvements similar to those obtained with traditional face-to-face interventions. the use of internet to administer ebt allows reducing the contact time between the patient and the therapist and this way reach people who otherwise would not receive treatment. therefore, the development of a ccbt for ad will mean an improvement in the delivery and dissemination of the current treatment programs. this is especially relevant for this problem considering the scarce attention received by the scientific community and the high interference caused in the patients' life. as far as we know, there is no ccbt program specifically designed for the treatment of ad. as a consequence, further research in this area is needed.

Eligibility criteria:
inclusion criteria: * be between 18 and 65 years of age. * meet dsm-v (apa, 2013) criteria for adjustment disorder. * be able to understand and read spanish. * be able to use a computer and have an internet connection at home. * have an e-mail address. * if having any medication, not change the drug or the dose during the treatment period. exclusion criteria: * be receiving other psychological treatment. * meet criteria for other severe mental disorder on axis i: abuse or dependence of alcohol or other substances, psychotic disorder, dementia or bipolar disorder. * meet criteria for a severe personality disorder or illness. * presence of risk of suicide or self-destructive behaviors.

Keywords: adjustment disorders online psychological treatments information and communication technologies internet
study of tl-895 in subjects with myelofibrosis or indolent systemic mastocytosis

Conditions: Myelofibrosis; Indolent Systemic Mastocytosis

Summary: this study evaluates tl-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of myelofibrosis (cohorts 1-3) or indolent systemic mastocytosis (cohort 5). participants must be diagnosed with myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive jaki treatment, or be diagnosed with indolent systemic mastocytosis.


Eligibility criteria:
cohorts 1-3 key inclusion criteria: * adults ≥18 years of age * confirmed diagnosis of pmf, post-pv mf, or post-et mf, as assessed by treating physician according to the world health organization (who) criteria * eastern cooperative oncology group (ecog) performance status of ≤2 * adequate hematologic, hepatic, and renal functions * mf symptoms as defined by having at least 2 symptoms with an average baseline (day -7 to day -1) score of at least 1 for each of the 2 symptoms per mfsaf v4.0 * cohort 3 only: ineligibility for jaki treatment with a platelet count of ≥ 25 and \< 50 x 10\^9/l key exclusion criteria: * prior treatment with any btk or bmx inhibitors * prior treatment with jaki within 28 days prior to study treatment * prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment cohort 5 key inclusion criteria: * adults ≥18 years of age * confirmed diagnosis of ism as defined by who diagnostic criteria based on review of bone marrow biopsy pathology report results * subject must have moderate-to-severe symptoms key exclusion criteria: * prior treatment with any btk or bmx inhibitors * prior treatment with avapritinib, bezuclastinib, or blu-263/elenestinib * diagnosis with another myeloproliferative disorder
renal tubular injury and transplant outcomes in cardiac recipients converting from ir tacrolimus to xr tacrolimus

Conditions: Chronic Kidney Diseases; Heart Transplant

Summary: immediate release (ir) tacrolimus peaks in the first two hours after administration. these peak levels are influenced by cyp3a5 expression with expressors requiring higher total daily doses with higher peak levels compared to non-expressors. tacrolimus xr (envarsus) is a once daily formulation with delayed absorption and lower peak levels while maintaining similar trough levels as seen with ir tacrolimus. a randomized trial of conversion from ir tacrolimus to tacrolimus xr in kidney transplant recipients have shown similar efficacy and adverse events between the two groups but no improvement in estimated gfr. however, urinary biomarkers of acute kidney injury associated with changes in tacrolimus dosing may be more sensitive then serum creatinine. the objective of this study is to assess renal tubular injury in heart transplant recipients who are converted from immediate release to tacrolimus xr. the hypothesis is that the delayed absorption and lower peak levels of tacrolimus xr will lead to less tubular injury and improved renal function without increased risk to the heart allograft.

the primary outcome is change in urinary ngal expression with conversion from ir tacrolimus to tacrolimus xr. in aim 1, changes in urinary biomarkers of tubular injury at 4 weeks after conversion to tacrolimus xr with stable trough levels will be assessed. these changes will be assessed by cyp3a5 expressor category that will be determined by genotyping of a single gene for variants. the changes in gfr using the creatinine-cystatin c ckd-epi equation will be assessed. in aim 2, the rate of rejection as defined as treated rejection within the last 30 days for any grade \> 1r or amr or acute graft dysfunction (lv ejection fraction drop \> 10%) will be looked. the cardiac allograft vasculopathy based on coronary angiography +/- ivus and right heart catheterization hemodynamics at baseline and 1 year post conversion will also be evaluated. in addition to changes in cardiac function, the changes in blood pressure, serum glucose, and cholesterol in the first year after conversion will be assessed.

Eligibility criteria:
inclusion criteria: * stable, heart-only transplant recipient within 10 years of transplantation * 18 -80 years old * currently taking ir tacrolimus * baseline egfr\> 30ml/min/1.73m2 exclusion criteria: * multiple organ transplant recipients * less than 18 years old * greater than 80 years old * heart-only transplants recipients with active malignancy, rejection, or greater than 10 years from transplantation

Keywords: immediate release tacrolimus extended release tacrolimus ir tacrolimus xr tacrolimus renal tubular injury heart transplant recipient chronic kidney disease
first in human study to assess the safety and the efficacy of an implantable nitinol device in the treatment of keratoconus

Conditions: Keratoconus

Summary: this study is a first in human clinical study addressed to evaluate the safety and efficacy of a novel intra-corneal nitinol device (investigational device; grosso® implant) for the treatment of advanced keratoconus disease of the eye.

the medical device under investigation is a sterile thin 8-mm diameter circular scaffold made of a nickel-titanium alloy (nitinol) that is intended as a permanent implant that is surgically inserted into the cornea in order to modify force by inducing a change in corneal shape and consequently improving vision. this study is aimed at adults with a stage 3-4 keratoconus, a central k reading \> 53.00 d and rms of coma aberration \> 3.5, which are not eligible for intrastromal corneal ring segments (icrs) and are recommended for keratoplasty. therefore, this study represents a salvage route to preserve the cornea. envisaged worst case scenario of failure of the experimental device patients would be redirected to keratoplasty.

Eligibility criteria:
inclusion criteria: * male and female ≥ 18 years old * not suitable for icrs and are recommended for keratoplasty * best distance spectacle corrected visual acuity (bdcsva) 1.30 - 0.40 logmar (0.05-0,40 decimal notation) * have stable or stabilized disease for 12 months (in case of cross-linking, it must have been done 12 months prior to intervention) * have a kc stage 3-4 (amsler-krumeich) with a central k readings \> 53.00 d and rms of coma aberration \> 3.5. * signed and dated informed consent form exclusion criteria: * inability of patient and/or relatives to understand the clinical investigation procedures and thus inability to give informed consent * untreated progressive kc * single functioning eye * minimum corneal thickness \< 400 μm * other ocular diseases (eyelids malposition, uveitis, ocular hypertension, glaucoma, cataract, retinal disorders) or corneal surgeries (refractive corneal surgery, keratoplasty), except corneal crosslinking * systemic collagenopathies and/or vasculitis, and other diseases that in the opinion of the principal investigator may be contraindicated
clinical study on acute radiotherapy-induced oral mucositis in patients with locally advanced head and neck tumors

Conditions: Head and Neck Cancer

Summary: to explore a more efficient and scientific clinical treatment plan for acute radiotherapy-induced oral mucositis(riom/rtom).it is hoped that the drug combination can more effectively improve the cure rate of acute riom,reduce the degree of oral mucosal injury and utilization rate of analgesic drugs,and reduce the occurrence of severe acute riom. almost all patients with head and neck will have riom because of receiving radiation therapy.studies have shown that the incidence of severe acute riom accounted for about 34% to 56%.there is no specific drug when acute riom is often accompanied by varying degrees of pain and infection in the mouth.severe riom seriously affects ingestion through the mouth and doesn't conducive to the treatment and prognosis of tumor diseases. to further explore the efficiency and advantages of the combined application of jeksung and anti-radiation spray in the treatment of acute riom at all levels,and provide more data support for relevant clinical treatment.explore whether the jeksung with combination of anti-radiation spray can effectively delay the occurrence of acute riom and delay the course of the disease.it will be expected to improve the quality of life of cancer patients ,reduce the occurrence of adverse events due during radiotherapy.


Eligibility criteria:
inclusion criteria: * head and neck cancer was confirmed by patholog * received radical radiotherapy, and were observed and treated by rtom in the stomatology department * age range: 18-75 years old * the estimated survival period is more than 6 months, and the card functional status score (kps) is 70 * there are no diseases that affect the treatment of oral mucositis, such as mouth opening restriction, sjogren's syndrome, etc. * sign the informed consent form exclusion criteria: * failed to complete radiotherapy, or delayed radiotherapy more than 2 weeks than planned * there are previous oral mucosal diseases, such as oral lichen planus and pemphigus, which are not effectively controlled or still need long-term drug treatment * there are other diseases that affect radiotherapy, such as severe organ function injury, chronic infectious diseases, etc. * had received radiotherapy for head and neck for other diseases; * the expected survival time is less than 6 months; * refuse to provide personal information or sign informed consent * the investigator judged other conditions that might affect the conduct of the clinical study and the determination of the study results.
pancreas screening in high risk individuals

Conditions: Pancreas Cancer Screening

Summary: pancreas cancer is the 11th most common cancer in canada but the 4th most common cause of cancer death because by the time pancreas cancer is detected, it is almost always too advanced for surgery. there are known factors that put individuals at higher risk for pancreas cancer. these include: certain genetic mutations, a family history of pancreas cancer, pancreas cysts and a new diagnosis of diabetes mellitus. individuals with these risk factors are recommended to undergo pancreas screening with blood tests and yearly imaging tests of the pancreas. our study will enroll patients with these risk factors and ensure they are managed as per guidelines. prospectively collected data will include: patient clinicodemographic details, lifestyle factors, screening test results, clinical outcomes and patient reported outcome measures.


Eligibility criteria:
inclusion criteria: * family history of pancreatic cancer, pathogenic variant increasing risk of pancreatic cancer, ipmn, new onset diabetes. exclusion criteria: * unable to give informed consnet